2011 Webinar: Top Tips for IRBs in 2011

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Overview

Top Tips for IRBs in 2011 focused on some of the key issues facing human research protections program (HRPP) and institutional review board (IRB) professionals.

Topics for discussion:

  • Summary of changes in the US Food and Drug Administration regulations and in the Declaration of Helsinki with respect to placebo controls;
  • Strategies for using flexibility in regulations to reduce IRB and investigator workload, including modifying research to reduce the level of regulatory review, using flexibility in consent documentation, and minimizing federal oversight
  • Tips for efficient processing of adverse events and other new information, including how to meet regulatory requirements for review of new information and to ensure prompt action on important information that does not involve adverse events
  • Overview of emerging initiatives to simplify oversight without negatively impacting human subjects protections, such as centralized IRBs and the clinical trial transformation initiative (CTTI)

Audience

The audience for this webinar included IRB chairs, administrators, staff, and members, institutional officials, and all those engaged in or with HRPPs/IRBs.

Faculty

Jeffrey A. Cooper, MD, MMM
Jeffrey A. Cooper, is a physician and consultant. He is currently a director in the clinical research services and healthcare compliance division of Huron Consulting Group, Inc. His previous positions include vice president for education and regulatory affairs for the Association for Accreditation of Human Research Protection Programs (AAHRPP), Inc. where he was responsible for the development and operation of the accreditation process, and associate medical director at Albany Medical Center where he was responsible for utilization management and quality improvement. He also served as IRB chair. Dr. Cooper received his undergraduate training at Rensselaer Polytechnic Institute, obtained his medical degree from Albany Medical College, and received a master’s in medical management from H. John Heinz III School of Public Policy and Management at Carnegie Mellon University. He trained in pediatrics at the University of Iowa and nuclear medicine at Albany Medical Center. He is board certified in pediatrics, nuclear medicine, and nuclear cardiology. After completion of his post-graduate training, Dr. Cooper trained in pulmonary physiology under a National Research Service Award and for 20 years was active in basic research, clinical research, and clinical practice.

Susan Ellenberg, PhD
Susan Ellenberg is professor of biostatistics and associate dean for clinical research, University of Pennsylvania School of Medicine. Dr. Ellenberg served as director at the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the FDA; prior to that, she served as the first chief of the biostatistics research branch in the division of AIDS, National Institute of Allergy and Infectious Diseases. Dr. Ellenberg is a fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. Her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was named WileyEurope Statistics Book of the Year for 2002. Dr. Ellenberg received an AB from Radcliffe College and a PhD in mathematical statistics from the George Washington University.